đź“‹ FDA Reference
acufex suture retriever sterile disposable
Acufex Microsurgical
Summary: The Acufex Suture Retriever is a sterile, disposable device used primarily in surgical procedures to retrieve sutures. It is commonly used by orthopedic surgeons and other specialists in minimally invasive surgeries.
FDA Clearance Information
Pathway
510K
Number
K881224 ↗
Decision Date
June 1, 1988
Product Code
GAE
Device Class
Class 1
Evidence
0 studies
The Acufex Suture Retriever was cleared through the FDA 510(k) pathway on June 1, 1988. It is manufactured by Acufex Microsurgical and classified as a Class 1 device under product code GAE.
What It Is
The Acufex Suture Retriever is a surgical instrument designed for the retrieval of sutures during procedures. It is sterile and disposable, ensuring a high standard of hygiene and reducing the risk of cross-contamination. The device is ergonomically designed to facilitate easy handling and precise control during surgery, making it an essential tool in minimally invasive procedures.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in arthroscopic procedures where sutures need to be retrieved from within joints. It is also utilized in other minimally invasive surgeries across various specialties, including gynecology and general surgery. The device is suitable for use in both hospital and outpatient surgical settings, catering to a wide range of patient populations.
Indications for Use
The Acufex Suture Retriever is indicated for use in surgeries where sutures need to be retrieved, such as in the repair of soft tissue injuries. It is particularly useful in procedures involving the joints, such as knee or shoulder arthroscopies.
Practical Considerations
The device is available in various sizes to accommodate different surgical needs and is compatible with standard suture materials. Its disposable nature eliminates the need for sterilization, saving time and resources in busy surgical environments.
Frequently Asked Questions
What is the Acufex Suture Retriever used for?
It is used to retrieve sutures during surgical procedures, particularly in minimally invasive surgeries.
What specialties typically use this device?
Orthopedic surgeons, gynecologists, and general surgeons commonly use this device in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in surgeries requiring suture retrieval, especially in arthroscopic and minimally invasive procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.